Recent news and posts
Med Tech-related technology assessments and clinical guidelines from NICE in August 2021
In August 2021, NICE published three Interventional Procedures Guidance (IPG):
- Magnetic resonance therapy for knee osteoarthritis;
- Laparoscopic removal of uterine fibroids with power morcellation;
- Hysteroscopic mechanical tissue removal (hysteroscopic morcellation) for uterine fibroids.
IPG is developed for most of the novel interventional procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit." Recommendations are not binding, although they are followed by providers and commissioners.
NICE concluded that evidence on the safety of magnetic resonance therapy for knee osteoarthritis raises no major concerns. However, evidence on the procedure's efficacy is inadequate in quality and quantity and shows no benefit over placebo. Therefore, this procedure should not be used unless it is part of a research study. Further research should be in the form of appropriately powered randomized controlled trials comparing the procedure with placebo. It should report patient selection and treatment protocols, including the number of sessions and magnetic field strength.
NICE concluded that evidence on the safety of laparoscopic removal of uterine fibroids with power morcellation shows potentially serious complications. In particular, there is a risk of spreading undiagnosed malignant tissue, which has a higher prevalence in people who are postmenopausal or over 50. Evidence on the procedure's efficacy is limited in quantity.
The following recommendations were made:
- For people who are postmenopausal or over 50, this procedure should not be used;
- For people who are premenopausal or 50 or under, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
NICE concluded that evidence on the hysteroscopic morcellation for uterine fibroids safety shows well-recognized infrequent but potentially serious side-effects. Evidence on its efficacy is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
MedTech Innovation Briefing (MIB) is the advice program of NICE for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations.
Six new MIBs were published in August 2021:
- PLASMA system with button electrode for electrovaporisation of the prostate. The PLASMA system is a bipolar electrosurgery system designed for surgical intervention for prostatic enlargement. The button electrode offers more efficient vaporization by removing tissue at a faster rate than other electrodes, such as loop and roller. Vaporization minimizes bleeding and allows the endoscopic view to remain clear throughout the procedure;
- Immunoscore, which is an assessment tool to predict the risk of relapse in patients with localized colon cancer. Immunoscore uses digital pathology and artificial intelligence (AI)-based algorithms to assess the density of CD3+ and CD8+ T-cells in the tumor and its invasive margins. It is a novel way of classifying the risk of relapse by measuring the person's immune response to the tumor;
- MMprofiler, a prognostic test to determine the risk of a multiple myeloma patient by classifying such patient into a "high" or "standard" risk group with the use of the well-validated SKY92 gene signature;
- Patient Status Engine (PSE), a technology for continuous remote monitoring of vital signs that uses wireless wearable biosensors to collect data on ECG, body temperature, oxygen saturation, and blood pressure. Healthcare professionals can view vital signs data in real-time at the central monitoring unit or authorized mobile devices;
- Lung texture analysis (Imbio), a digital technology that uses a CALIPER algorithm (Computer-Aided Lung Informatics for Pathology Evaluation and Rating) to analyze standard chest CT images and map the presence of abnormal lung textures. It is used for automated measurement of interstitial lung disease, idiopathic pulmonary fibrosis, and other fibrotic conditions;
- Colli-Pee, a urine container that allows collecting the first void without the person needing to interrupt the flow of urine and standardizes the volume of urine collected.
Five new or updated clinical guidelines were published in August:
- Antenatal care. The guideline covers organization and delivery of antenatal care, routine antenatal clinical care (examinations and investigations, venous thromboembolism, gestational diabetes, pre-eclampsia and hypertension in pregnancy, monitoring fetal growth and wellbeing, breech presentation), information and support for pregnant women and their partners, and interventions for common problems during pregnancy;
- Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) and obesity hypoventilation syndrome (OHS) in over 16s. This guideline covers initial assessment, diagnosis, and management of OSAHS, OHS, and COPD–OSAHS overlap syndrome. Recommendations were made on the use of diagnostic tests (home/hospital respiratory polygraphy, home oximetry, polysomnography, CO2 monitoring during sleep), continuous positive airway pressure (CPAP), and non-invasive ventilation. NICE also made recommendations for further research;
- Chronic kidney disease: assessment and management. New and updated recommendations were provided on investigations, classification, frequency of monitoring, risk assessment, referral criteria, and blood pressure control in chronic kidney disease;
- Babies, children, and young people's experience of healthcare;
- Bronchiolitis in children: diagnosis and management.
See the full details here.
This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). First EU issues of both newsletters are available for download free-of-charge.
Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks).